FDA's proposed e-cigarette rules draw mixed review

A man smokes an e-cigarette as he visits Vapexpo, an international exhibition to promote e-cigarette, in Bordeaux, western France, on March 13, 2014. E-cigarettes are battery-powered gadgets that deliver nicotine through a vapor that may be fruit or candy-flavored.(Photo: NICOLAS TUCAT, AFP/Getty Images)

Proposed U.S. regulation of electronic cigarettes and other tobacco products is prompting industry concern that it could slow innovation and public health worries that the rules won't go far enough.

The Food and Drug Administration's 241-page proposal, unveiled Thursday, will ban the sale to minors of tobacco products that are currently unregulated including e-cigarettes, cigars, pipe tobacco and hookahs. The rules will also require ingredient disclosure, federal approval and warning labels but don't ban flavors such as bubble gum, Internet sales to adults or TV ads (unless they make health claims).

The rules are "not as restrictive as some had feared," said Bonnie Herzog, tobacco industry analyst for Wells Fargo Securities. She said her main concern is the potential stifling of e-cigarette innovation, which she says could slow the growth of the now $2 billion industry.

The battery-powered devices have sparked virulent debate about safety. They don't have as many harmful chemicals as conventional cigarettes, which they often resemble, but they do contain nicotine, which is addictive and is derived from tobacco leaves. They heat a nicotine liquid into vapor that's inhaled. Supporters say they help smokers kick the habit, but critics say they enable users to avoid smoke-free laws and may lure children into a tobacco addiction.

Nicotine can be safe when regulated, but with e-cigarettes, "It's buyer beware," says Mitch Zeller, director of the FDA's Center for Tobacco Products. He says consumers have no idea what they're inhaling because e-cigarette makers don't have to disclose ingredients, test for safety or adhere to standards.

Many public health groups welcomed the FDA's proposal, more than three years in the making, but some faulted it for not restricting flavors or advertising. "The association is disappointed that the FDA has chosen to delay action in this area," said Nancy Brown, the American Heart Association's CEO.

"It's an enabling regulation," Zeller says, adding it could open the door later to limits on flavors and advertising. Once the rules are finalized, which could take years, he says e-cigarettes will have to carry a label that warns, "Nicotine is addictive."

Matt Myers, president of the Campaign for Tobacco-Free Kids, an anti-smoking group, says the FDA needs to finalize its rules quickly to limit the number of teens drawn to flavored small cigars and e-cigarettes. He says its proposal also needs to drop the potential exemption for premium cigars, which are wrapped in whole tobacco leaf and used primarily by adults.

"It's disturbing FDA would even consider exempting any form of tobacco product, all of which cause disease," Myers says.

The Cigar Association of American, in a statement, applauded the agency for acknowledging differences within its industry and avoiding a "one-size-fits-all regulation."

For the now diffuse e-cigarette industry, the proposed rules could lead to a consolidation as smaller companies struggle with the costs of compliance.

"There's going to be some pain," says Jason Healy, president of blu eCigs, the leading e-cigarette company in the U.S. market, citing the costs. But he says "we're in the public health space" and need to produce responsible products.

"I like the overall tone" of the proposal, Healy says, adding the FDA is taking a "scientific-based" approach.

Miguel Martin, president of LOGIC, the second-largest e-cigarette company, agrees. "I'm encouraged by it," Martin says, noting the FDA isn't simply applying all its current restrictions on regular cigarettes to e-cigarettes. He says he is concerned that the rules could slow innovation in his industry by eventually requiring FDA approval before products enter the market or are altered. But he adds: "We're at the beginning of a long process, and we'll see how it goes."